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FDA Drug Application 021037 by BAYER HLTHCARE

Application Number021037
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/10/2000N9197000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21037_Magnevist.pdf 6/9/2004
AP03/10/2000N31164000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm 12/21/2011
AP010/24/2000SCM       
AP03/6/2001SCM       
AP011/5/2001SCM       
AP03/20/2002SCP       
AP010/29/2002SCM       
AP09/17/2004SLR10226010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21037s010ltr.pdf 9/17/2004
AP08/19/2010SLR26315011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019596s034,021037s011ltr.pdf 8/31/2010
AP08/19/2010SLR26413011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019596s034,021037s011lbl.pdf 9/7/2010
AP09/13/2006SLR14825014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021037s014ltr.pdf 9/15/2006
AP09/4/2007SLR17751018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019596s043,021037s018lbl.pdf 9/6/2007
AP09/4/2007SLR17765018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019596s043, 021037s018ltr.pdf 9/6/2007
AP05/22/2009SCS22608019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019596s045,021037s019lbl.pdf 5/25/2009
AP05/22/2009SCS22659019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019596s045,021037s019ltr.pdf 5/29/2009
AP012/20/2010SLR27315023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021037s023lbl.pdf 12/20/2010
AP012/20/2010SLR27356023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019596s049,021037s023ltr.pdf 12/22/2010
AP03/29/2012SLR32314025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021037s025lbl.pdf 3/29/2012
AP03/29/2012SLR32329025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019596s051,021037s025ltr.pdf 4/2/2012
AP010/17/2013SLR37460029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019596Orig1s056,021037Orig1s029ltr.pdf 10/18/2013
AP010/17/2013SLR37506029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019596s056,021037s029lbl.pdf 10/22/2013
AP06/11/2014SLR39523030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019596Orig1s057,021037Orig1s030ltr.pdf 6/12/2014
AP06/11/2014SLR39571030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019596s057,021037s030lbl.pdf 6/17/2014
AP07/31/2015SLR43556031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021037Orig1s031ltr.pdf 8/3/2015
AP07/31/2015SLR43929031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021037s031lbl.pdf 9/21/2015




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